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Kangstem Biotech strives to develop an innovative new drug for patients suffering from rare and incurable diseases.
Japan Approves Generation of Type 2 Regenerative Medicine
19
2025.02
Kangstem Biotech has received approval from the Japanese Ministry of Health, Labor, and Welfare for its ‘Type 2 Regenerative Medicine Provision Plan’ using adipose stem cells.
Kangstem Biotech has received approval from the Japanese Ministry of Health, Labor, and Welfare for its ‘Type 2 Regenerative Medicine Provision Plan’ using adipose stem cells. We aims to launch its business within the first quarter, supplying Japanese medical institutions with adipose stem cells derived from the adipose tissue of chronic pain patients through separation and incubation processes.
In Japan, regenerative medicine is largely categorized into three risk levels, with Type 2 representing a medium-risk classification. This group includes autologous stem cells, somatic cells, cultured cells, and non-homologous medical technologies.
In 2024, Kangstem Biotech established the groundwork for stem cell production at Japanese regenerative medicine institutions by obtaining approval from the domestic Good Manufacturing Practice (GMP) Center for the manufacture of specific cell-processed products. With the final approval of the Type 2 Regenerative Medicine Provision Plan, the company explains that it has now completed all necessary preparations to launch its regenerative medicine business in Japan.
Kangstem Biotech is currently coordinating with medical institutions in Tokyo, Osaka, and other regions in Japan to confirm patient treatment plans and schedules, aiming to administer the treatment within the first quarter of this year. With this approval, the company seeks to establish mid- to long-term revenue streams while expanding the application of regenerative treatments to high-demand conditions such as aging and osteoarthritis.
In addition, We aims to penetrate the Japanese regenerative medicine market and provide patient treatments using “SELAF”, its proprietary high-quality stem cell technology. This platform features advanced methods for isolating and cultivating stem cells found in extremely small quantities, along with an incubation medium technology that ensures high proliferation capacity and consistent cell quality.
Japan’s regenerative medicine market is projected to grow from JPY 290 billion(approximately USD 1.9 billion) in 2025 to JPY 910 billion(approximately USD 5.9 billion) by 2040. Notably, chronic pain diseases account for a substantial share of stem cell-based regenerative treatments, representing approximately 25.8% of the market, according to the data from the Japanese Society for Regenerative Medicine. Given the high demand, strong patient interest and steady sales growth are anticipated.